SBC 55 - Blood pressure monitor SANITAS - Free user manual and instructions

USER MANUAL SBC 55 SANITAS

Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

1. Getting to know your instrument

The wrist blood pressure monitor is used for non-inva- sive measurement and monitoring of adults‘ arterial blood pressure. You can use it to measure your blood pressure quickly and easily, storing the results and displaying the pro- gression of readings. A warning is issued for anyone suffering from cardiac arrhythmia. The values determined are classified and graphically evaluated according to WHO guidelines. The device also has an acoustic voice output.

• Always measure your blood pressure at the same time of day, in order to ensure that values are com- parable.

• Relax for approx. 5 minutes before each measure- ment.

• You should wait five minutes before measuring a second time.

• The readings that you take may only be used for information purposes – they are not a substitute for a medical examination! Discuss your results with the doctor. Never use them to make medical decisions independently (e.g. regarding medication and dosa- ge thereof).

circulation on one arm is restricted as a result of chronic or acute vascular disease (including vaso- constriction), the precision of any wrist measure- ment is impaired. In this case, use a blood pressure monitor for the upper arm.

• There may be incorrect measurements where there is cardiocirculatory disease, as well as with very low blood pressure, circulatory disorders, dysrhythmia and other preexisting diseases.

• Only use the instrument on persons whose wrist has the right circumference for the instrument.

• You may only operate the blood pressure monitor with batteries. Note that it is only possible to save data when your blood pressure monitor is receiving power. As soon as the batteries are dead, the date and time on the blood pressure monitor are lost. Any measurement results that have been stored are however retained.12

• The automatic switch-off function switches off the blood pressure monitor in order to preserve the bat- teries, if no button is pressed within one minute. Storage and Care

• The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instrument‘s service life depend on careful handling. – You should protect the device from impact, moisture, dirt, major temperature fluctuations and direct exposure to the sun‘s rays. – Never drop the device. – Do not use near strong electromagnetic fields, i.e. keep it away from any radio systems and mobile phones. – Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.

• Do not press any buttons until the cuff is in position.

• If the instrument is not used for any length of time, we recommend removing the batteries. Advice on batteries

• Batteries can be fatal if swallowed. You should the- refore store the batteries and products where they are inaccessible to small children. If a battery has been swallowed, call a doctor immediately.

• Batteries should not be charged or reactivated with any other means, nor should they be taken apart, thrown in the fire or short-circuited.

Remove the batteries from the instrument if they are worn out or if you are not going to use the instru- ment for any length of time. This prevents any da- mage as a result of leakage. Always replace all the batteries at the same time.

Never use different types of battery, battery brands or batteries with different capacities. You should preferably use alkaline batteries. Repair and disposal

• Batteries do not belong in domestic refuse. Used batteries should be disposed of at the collection points provided.

• Never open the instrument. If these instructions are not heeded, the warranty will be null and void.

• Never attempt to repair the instrument or adjust it yourself. We can no longer guarantee perfect func- tioning if you do.

• Repairs may only be performed by Customer Serv- ice or authorized dealers. However, always check the batteries and replace them if necessary prior to making any complaint.

• The appliance should be disposed of accor- ding to Regulation 2002/96/EC-WEEE (Waste Electrical and Electronic Equipment). In case13 of queries, please contact the municipal authorities responsible for waste disposal in your area.

Icons in the display:

1. Systolic pressure

2. Diastolic pressure

5. Number of memory space

4. Prepare measurement

• Remove the battery cover (left side of the unit).

• Insert two 1.5 V micro batteries (alkaline, type LR 03). Make absolutely sure that you insert the batte- ries with the correct polarity as marked. Do not use rechargeable batteries.

• Replace the battery cover carefully. If the ‚change battery‘ icon is displayed, measure- ment is no longer possible and you must replace all the batteries. Once batteries have been removed from the device, the time must be reset. Any measurement results that have been stored are however retained. Note: You will find these markings on batteries containing harmful sub- stances: Pb = battery containing lead, Cd = battery containing cadmium, Hg = battery containing mercury. Setting date and time It is vital to set date and time. Only in this way is it possible to save and subsequently retrieve your mea- sured values with the right date and time. Time is shown in 24 hour format. Pb Cd Hg

‘ and ‚M‘ simultaneously. The year starts flashing. Set the year with ‚M‘ and confirm with ‚

• Set the month, day, hour and minute and confirm in each case with ‚

Voice function You can set the voice function in the switched off state. The device offers 3 languages (English, German, Spanish). The device is set to German on delivery. To change the language selection, press and hold down the ‚M‘ button until the desired language appears in the display. L1-German L2-English L3-Spanish L0-Language off The device changes the language automatically if you keep the ‚M‘ button pressed. You are informed of the language acoustically each time it changes. Release the ‚M‘ button to confirm your desired language. Volume adjustment: After selection of the language, the bar graph of the WHO classification in the left part of the display flashes and displays the current volume. You can change the volume by pressing and holding down the ‚M‘ button – the higher the bar rises, the lou- der the acoustic output. Press the ‚M‘ button again to confirm the selected vo- lume and to switch off.

• Bare your left wrist, making sure that the circulation in the arm is not restricted by any clothes etc. that are too tight. Position the cuff on the inside of your wrist.

• Fasten the cuff with the Velcro fastening so that the upper edge of the monitor is positioned approx. 1 cm below the ball of your thumb.

• The cuff has to be fitted tightly around the wristbut should not constrict it. Important: The instrument should only be operated with the original cuff.15 Correct posture

• Rest for approx. 5 minutes before each measurement. Otherwise there may be divergences.

• You can perform the measurement either sitting or lying down. It is essential to support your arm and have it at an angle. Always make sure that the cuff is level with your heart. Otherwise there may be serious divergences. Relax your arm and the palms of your hands.

• In order not to distort the result, it is important to keep still during the measurement and not talk. Measuring blood pressure

• Switch on the blood pressure monitor with the ‚ ‘ button.

• Before the measurement, the last saved test result is briefly displayed. If there is no measurement in the me- mory, the instrument always displays the value ‚0‘.

• The cuff is pumped up to 180 mmHg. Cuff air pres- sure is released slowly. If a tendency towards high blood pressure is already detectable, the cuff is pumped up again and cuff pressure increased further. As soon as a heart rate is detected, the heart rate symbol is displayed.

• Heart rate, systolic and diastolic blood pressure are displayed.

• You can interrupt measurement at any time by pres- sing the ‚ ‘ button.

• ‚Er_‘ appears if it has not been possible to perform the measurement properly. Observe the section in these instructions on error messages/troubleshoo- ting and repeat the measurement.

• The test result is saved automatically. Evaluating results Cardiac arrhythmia: This instrument can identify possible cardiac arrhyth- mia disorders during measurement and if necessary indicates the measurement with the flashing icon

This may be an indicator for arrhythmia. Arrhythmia is a condition where the heart rhythm is abnormal as a result of defects in the bioelectrical system controlling the heart beat. The symptoms (omitted or premature heart beats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress or lack of sleep. Arrhythmia can only be ascer- tained through examination by your doctor. Repeat the measurement if the flashing icon

displayed after the measurement. Please note that you should rest for 5 minutes between measurements and not talk or move during the measurement. If the icon appears often, please contact your doctor. Any

• • • • • • • • • • • • •16 self-diagnosis and treatment based on the test results may be dangerous. It is vital to follow your doctor‘s instructions. WHO classification: According to WHO Guidelines/Definitions and the la- test findings, the test results can be classified and evaluated according to the following chart: Range of blood pressure values Systolic (in mmHg) Diastolic (in mmHg) Measure Grade 3: Severe hypertension >=180 >=110 Seek medical advice Grade 2: Moderate hypertension 160 -179 100 -109 Seek medical advice Grade 1: Mild hypertension 140 -159

90 - 99 Have it checked regularly by doctor

High-normal 130 -139

85 - 89 Have it checked regularly by doctor

80 - 84 Check it yourself

Optimal <120 <80 Check it yourself Source: WHO, 1999 The bar graph in the display and the scale on the unit indicate the range of the blood pressure which has been recorded. An accoustic evaluation of your mea- surement also follows. If the values for systolic and diastolic pressure are in two different WHO ranges (e.g. systolic in the high- normal range and diastolic pressure in the normal range) the graphic WHO classification on the unit in- dicates the higher range (high-normal in the example described).

6. Saving, retrieving and deleting results

• The results of each successful measurement are stored together with date and time. With more than 60 items of measured data, the earliest items of data measured are lost.

• In order to retrieve measurement results again, press the memory button ‚M‘. The instrument first displays the number of memory spaces occupied and then au- tomatically switches to the last saved test result. If you continue pressing the memory button ‚M‘, the last results in each case are measured are17 displayed with date, time and graphic WHO classifi- cation.

• You can clear the memory by holding down the me- mory button ‚M‘ for 3 seconds.

7. Error messages/troubleshooting

In case of faults, the ‚Er_‘ message appears in the display. Error messages can occur when

• inflation takes longer than 3 minutes (Er6 appears in the display),

• the cuff is too tight or too loose (Er3 or Er4 appears in the display),

• the blood-pressure values are unusually high or low (Er1 or Er2 appears in the display),

• the inflation pressure is higher than 300 mmHg (Er5 appears in the display),

• there is a system or device error (Er0, Er7, Er8, Er9, ErA or ErB appears in the display)

• the batteries are almost flat; the batteries must be replaced. In the above cases, you must repeat the measure- ment. Make sure that the cuff tube is properly inserted and that you do not move or talk. Re-insert the batteries if necessary, or else replace them.

8. Cleaning and Care

• Clean your blood pressure computer carefully using only a slightly moistened cloth.

• Do not use any detergents or solvents.

• Never hold the instrument under water as otherwise liquid can penetrate and damage the instrument.

• Never place any heavy objects on the instrument.

9. Technical details

Model no. SBC 55 Measurement Oscillating, non-invasive blood method: pressure measurement on the wrist Measurement range Pressure 0-300 mmHg, heart rate 40-180 beats/minute Precision of Systolic ± 3 mmHg / pressure reading diastolic ± 3 mmHg pulse ± 5% of displayed value Measurement Max. admissible standard uncertainty deviation according to clinical examination: systolic 8 mmHg / diastolic 8 mmHg Memory 1 x 60 storable data lines Dimensions L 82 x W 77 x H 31 mm Weight Approx. 140 g Cuff size For a wrist circumference of approx. 140 to 195 mm18 Admissible operating +5 °C to +40 °C, 40-80% temperature relative humidity Admissible -20 °C to +55 °C, 10-95% storage temperature relative humidity Power supply 2 x 1.5 V Micro (Alkaline Type LR 03) Battery life For 250 measurements Accessories Storage box, instructions for use, 2 x AAA batteries Classification Application part type B Explanation of Application part type B symbols Caution! Read the Instructions for Use.

• This unit is in line with European Standard EN60601-1-2 and is subject to particular precau- tions with regard to electromagnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this in- strument. For more details, please contact customer service at the address indicated.

The instrument is in line with the EU Medical Pro- ducts Directive 93/42/EC, the German medical prod- ucts act and European standards EN1060-1 (non- invasive blood pressure monitors, Part 1: general requirements) and EN1060-3 (non-invasive blood pressure monitors, Part 3: Supplementary Require- ments for Electromechanical Blood Pressure Meas- urement Systems).

• If you are using the instrument for commercial or economic purposes, you must check measurement precision regularly in accordance with the ‚Operators‘ Ordinance on Medical Products‘. Even in the case of private use, we recommend checking measurement precision every two years at the manufacturers.19